Efficacy of the 6-month thrice-weekly regimen in the treatment of new sputum smear-positive pulmonary tuberculosis under clinical trial conditions.

BACKGROUND: Under the Revised National Tuberculosis Control Programme of India, patients with new smear-positive pulmonary tuberculosis are treated with a thrice-weekly regimen of antitubercular drugs (2H(3)R(3)Z(3)E(3)/4H(3)R(3) [H isoniazid, R rifampicin, Z pyrazinamide and E ethambutol]) for 6 months. We conducted a retrospective analysis of the efficacy andtolerability of this regimen under clinical trial conditions in HIV-negative patients with newly diagnosed smear-positive pulmonary tuberculosis. METHODS: We retrospectively analysed the data on patients assigned to the control regimen (2H (3)R(3)Z(3)E(3)/4H(3)R(3)) in two clinical trials during 2001-06 at the National Institute for Research in Tuberculosis, Chennai, India. RESULTS: Of the 268 patients treated with this regimen, data for efficacy analysis were available for 249. At the end of treatment, of 249 patients, 238 (96%) had a favourable status. Treatment failure occurred in the remaining 11: 7 in whom the organisms were initially drug-susceptible and 4 with initial drug resistance. Of the 238 patients who had a favourable status at the end of treatment, 14 (6%) had recurrence of tuberculosis during the following 24 months. In the intention-to-treat analysis, 245 (94%) of 262 patients had a favourable status at the end of treatment. Of the 28 patients with initial drug resistance, 24 (86%) had a favourable outcome. Only 4 of these 24 patients were found to have recurrence of tuberculosis in 2 years of follow-up. Among the 221 patients initially infected with drug-susceptible organisms, drug resistance did not develop in any of the 7 patients in whom the treatment failed or the 10 who had recurrence of tuberculosis. Further, 5 of the 7 patients in whom the treatment failed continued to excrete drug-susceptible bacilli at 6 months. Adverse drug reactions were observed in 38 (14%) of the 262 patients. Only 3 (1.1%) needed a modification in the treatment. CONCLUSION: This thrice-weekly 6-month regimen of antitubercular drugs, when administered under full supervision, is associated with a high rate of favourable treatment outcomes in HIV-negative patients with newly diagnosed sputum smearpositive pulmonary tuberculosis. There are few adverse drug reactions in these patients.

Gender disparities in tuberculosis: report from a rural DOTS programme in south India.

SETTING: Tiruvallur District, south India. OBJECTIVES: To examine gender differences in tuberculosis among adults aged >14 years with respect to infection and disease prevalence, health care service access, care seeking behaviour, diagnostic delay, convenience of directly observed treatment (DOT), stigma and treatment adherence. METHODS: Data were collected from 1) community survey, 2) self-referred out-patients seeking care at governmental primary health institutions (PHIs), 3) tuberculosis suspects referred for sputum microscopy at PHIs, and 4) tuberculosis patients notified under DOTS. Community survey results were compared with those for patients notified at PHIs. RESULTS: In the community, 66% of males and 57% of females had tuberculosis infection. The prevalence of smear-positive tuberculosis was 568 and 87/100,000, respectively, among males and females. Fewer males than females attended PHIs (68 men for every 100 women). Females constituted 13% of all smear-positive patients detected in the community survey, and 20% of those detected at PHIs (P < 0.05). The probability of notification decreased significantly with age among both males and females. Significantly more females than males felt inhibited discussing their illness with family (21% vs. 14%) and needed to be accompanied for DOT (11% vs. 6%). Males had twice the risk of treatment default than females (19% vs. 8%; P < 0.01). CONCLUSIONS: Despite facing greater stigma and inconvenience, women were more likely than men to access health services, be notified under DOTS and adhere to treatment. Men and elderly patients need additional support to access diagnostic and DOT services.